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Renal Arterial Resistive Index Versus Novel Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury (RRIBIOSAKI)

2021年2月27日 更新者:Islam Elsayed Mohamed Ahmed

Renal Arterial Resistive Index Versus Novel Serum and Urinary Biomarkers for Early Prediction of Sepsis Associated-acute Kidney Injury in Critically Ill Patients

Populations at high risk of Sepsis-Associated Acute Kidney Injury (SA-AKI) have been identified. Sources of sepsis, in particular, bloodstream infection, abdominal and genitourinary sepsis, and infective endocarditis, are associated with a higher likelihood of developing AKI. Similar to the poor outcome of patients with sepsis, delayed administration of appropriate antimicrobial therapy was shown to be an independent predictor of the development of AKI. Incremental delays in antimicrobial delivery after the onset of hypotension showed a direct relationship with the development of AKI. The need for sensitive, simple and time-applicable biomarker to predict AKI development after renal insult is urgent.

Serum creatinine (sCr) and urea are used routinely for the diagnosis of AKI. However, these parameters are not accurate for the diagnosis of AKI. Cystatin C. (CysC) is suggested to be a good biomarker because of its constant rate of production, almost filtered by glomeruli (99%), has no significant protein binding and not secreted by renal tubule. Neutrophil gelatinase-associated lipocalin (NGAL) is recently identified and extensively investigated as a most promising early marker of AKI. Urinary NGAL is not only effective in detection of AKI but also its degree of expression might distinguish among AKI, prerenal azotemia and chronic kidney disease, and it is detectable before the accumulation of serum creatinine.

Ultrasonography (US) is used routinely to assess renal morphology. Renal Resistive Index (RRI) is a non-invasive Doppler-measured parameter that is directly correlated with intra-renal arterial resistance. RRI is defined as [(peak systolic velocity - end diastolic velocity)/ peak systolic velocity]. It theoretically ranges from 0 to 1 and it is normally lower than 0.7 with age differences. RRI calculation was found to be useful as an early indicator of the vascular resistance changes and in the determination of the optimal systemic hemodynamics required for renal perfusion.

The aim of this study is to compare the ability of arterial renal resistive index (RRI), serum and urinary neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C (CysC) in early diagnosis and predicting the persistence of acute kidney injury in septic patients.

研究概览

地位

完全的

详细说明

All included patients in this study will be assessed for the following:

  1. Data Collection

    • Complete history taking (age, sex, illness, medications, etc.).
    • Complete physical examination (Glasgow coma scale (GCS), temperature, blood pressure, urine output, heart rate, respiratory rate and chest auscultation).
    • SOFA score, APACHE II score, and Quick SOFA (qSOFA).
    • Routine laboratory investigations and Coagulation profile.
    • C-reactive protein (CRP), and Serum lactate.
    • Complete sepsis workup (chest x-ray, urine analysis, abdomen and pelvis ultrasound, microbiological cultures) to identify the source of sepsis.
  2. Renal Biomarkers

    - Serum and urinary samples will be collected directly at time of enrollment (within 2 hours from admission). It will be assayed for serum creatinine, serum neutrophil gelatinase-associated lipocalin (NGAL), urinary NGAL and serum Cystatin C (CysC). Then, it will be repeated at day 3.

  3. Ultrasound evaluation of kidneys and renal Doppler

    • In each patient, both kidneys will be examined with real-time ultrasound (US) with a 3.75-MHz transducer (ACUSON X 300). Pulsed Doppler US evaluation of the intrarenal arteries will be obtained at the same respective scanning frequencies. The color Doppler functions are set for a study focused on interlobar arteries, that is, the highest gains possible, the use of the lowest filters and a low pulse repetition frequency (PRF) of 1-1.5 kHz that must be preferred while always limiting the aliasing phenomenon.
    • The renal resistance index (RRI, [peak systolic frequency shift-minimum diastolic frequency shift]/ peak systolic frequency shift) will be calculated from calibrated software. (26) All measurements will be performed by the same examiner.
    • The renal resistive index (RRI) will be measured at time of enrollment (within 2 hours from admission) and 24 hours after admission.
  4. Treatment All patients will receive the standard treatment for management of sepsis on the guidelines of SCC (sepsis-3). The protocol of treatment will not be changed during the study time.
  5. Follow up - All patients will be followed up using urine output (UOP), serum creatinine, KDIGO (Kidney Disease Improving Global Outcomes) classification, the use of vasopressors and need for renal replacement therapy (RRT).

研究类型

观察性的

注册 (实际的)

75

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Alexandria、埃及、21563
        • Alexandria Main University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

- Critically ill patients recently admitted with sepsis.

描述

Inclusion Criteria:

  • Adult patients (aged above 18 years) recently admitted with sepsis

Exclusion Criteria:

  • Pregnant Females
  • Patients with renal transplant.
  • Patients with End Stage Renal Disease (ESRD).
  • Patients with Chronic Kidney Disease (CKD) known with history, laboratory or ultrasonographic evaluation with chronic nephropathic changes.
  • Patients with renal artery stenosis.
  • Patients with obstructive uropathy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Acute Kidney Injury
大体时间:7 days from inclusion
AKI is defined according to KDIGO (Kidney Disease Improving Global Outcomes)
7 days from inclusion
Transient Acute Kidney Injury
大体时间:7 days from inclusion
Transient AKI is defined as AKI with a cause of renal hypoperfusion and recovery within 3 days after inclusion. Recovery from AKI is defined as urine output normalization and/or serum creatinine decrease by 50% and/or serum creatinine normalization to its measured or estimated baseline level.
7 days from inclusion
Persistent Acute Kidney Injury
大体时间:7 days from inclusion
Persistent AKI is defined as persistent serum creatinine rise or oliguria after 3 days.
7 days from inclusion

次要结果测量

结果测量
措施说明
大体时间
Mortality
大体时间:28 days from inclusion
All cause 28-days mortality
28 days from inclusion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ibrahim Ibrahim, MSc、Assistant Lecturer of Critical Care Medicine, Kafr Elsheikh University
  • 研究主任:Taysser Zaitoun, MD、Professor of Critical Care Medicine, Alexandria University
  • 研究主任:Mohamed Megahed, MD、Professor of Critical Care Medicine, Alexandria University
  • 学习椅:Hisham Elghonemy, MD、Lecturer of Nephrology, Alexandria University
  • 学习椅:Doaa Emara, MD、Lecturer of Radiodiagnosis, Alexandria University
  • 学习椅:Islam Ahmed, PharmD、Clinical Pharmacy Specialist, Alexandria University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年5月15日

初级完成 (实际的)

2021年2月28日

研究完成 (实际的)

2021年2月28日

研究注册日期

首次提交

2019年1月8日

首先提交符合 QC 标准的

2019年1月8日

首次发布 (实际的)

2019年1月10日

研究记录更新

最后更新发布 (实际的)

2021年3月2日

上次提交的符合 QC 标准的更新

2021年2月27日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

The summary of all relevant data

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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